Pharmaron US Lab Services的动态

#Medtech innovators and startups - check out this upcoming FDA-NIH webinar on May 20 at 11:30am EST! Register here: https://lnkd.in/diZCVgsS. This webinar will cover resources to help with regulatory and funding challenges that may be encountered during medical device development. FDA/CDRH will present information on best practices for early-stage regulatory submissions, IDE, Early Feasibility Studies, Breakthrough designation. CDRH speakers will also introduce the Total Product Life Cycle Advisory Program Pilot (TAP), a new program aimed at de-risking the path to device commercialization, followed by Q/A. NIH will provide information on funding opportunities through SBIR/STTR and additional support services available to innovators. #medicaldevice #medicaldevices

Should be a very informative webinar on May 20th for medtech companies in the development stage put on by Kai Kadoich and his colleagues at FDA and CDRH! Click the link to register!

?? Did you know that Edwards Lifesciences is taking part in the HEU-EFS project that has officially launched in Europe? ? This @IHIEurope research project will develop a Harmonized Approach to Early Feasibility Studies for Medical Devices in the ????. This consortium, involving 22 public and private organizations across Europe, aims to improve the early evidence generation pathway for medical device innovations. The goal is to facilitate access to innovative technologies for patients with unmet needs, increase the attractiveness of the EU for innovators, and support healthcare system efficiencies. Learn more at https://lnkd.in/ewXdnRH2 #HEUEFS #CERGAS #Bocconi #EdwardsLifesciences #IHITransformingHealth #PatientCare #Evidence #Leadership #MedTech #Innovation #EFS #regulatory #ClinicalTrial #Edwards #EdwardsLifesciences

I will attend the #MedTechSummit2024 next week, I am?happy to connect with you and discuss your regulatory needs for medical devices and how Lumis International GmbH can support you. See you there! #MedTech?#MedTechSummit2024?#RegulatoryServices #MedicalDevices?#LumisInternational #LumisLifeScienceConsulting?#MedicalDeviceRegulation?#MDR

Today I’d like to take the opportunity to spotlight one of DB Group Investments' and North First Ventures - N1V’s portfolio company BioT Medical. As a visionary entity within the DB Group, BioT Medical has been a trailblazer in the MedTech sector since its inception in 2018. What truly sets BioT Medical apart is its groundbreaking cloud-based platform. This innovation enables seamless and instantaneous connections among caregivers, patients, pharmaceutical companies, and medical device firms. In today's rapidly evolving healthcare landscape, the importance of data security and operational reliability cannot be overstated. BioT Medical’s recent achievement of SOC 2 Type II certification is a testament to their unwavering commitment to these principles. I think BioT Medical's work exemplifies the transformative potential of collaboration across borders. Their technology is not just a tool for improving healthcare; it's a bridge that connects diverse stakeholders, fostering a more integrated and effective global healthcare ecosystem. The dedication and passion of BioT Medical’s team are truly inspiring. They share a unified vision of making world-class medical care accessible to all, and their innovative spirit is what makes this company exceptional. As we look to the future, it's clear that companies like BioT Medical will play a pivotal role in shaping the healthcare landscape. For those in the MedTech and investment communities, what challenges and opportunities do you anticipate in ensuring data security and operational reliability? Check out BioT Medical’s vision here > https://lnkd.in/egpi6bzt #MedTech #Healthcare #ConnectedCare

The European Parliament has called on the European Commission to address critical issues within the Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR) by Q1 2025. The goal? Tackle the bottlenecks that slow down device approvals, especially for small to medium-sized companies, and ensure patients have access to life-saving technologies. MedTech Europe supports these changes, advocating for clear, consistent certification timelines and streamlined processes to ease the regulatory burden. With a deadline on the table, we could see impactful changes soon—essential for the industry’s growth and efficiency in Europe. Exciting times ahead for medtech as reforms could open doors to more innovation-driven roles across the EU. https://lnkd.in/eeCSqWei #Medtech #EURegulations #Innovation

The clinical research landscape for IVD and medical devices is experiencing a rapid evolution driven by technological advancements. Our new article https://lnkd.in/eSWp5gem from Bill T.,?Beaufort's SVP and Chief Technology Officer,?discusses the?wide variety of systems and tools that help optimize operations within the clinical research paradigm.?Beaufort's focus is on integrating?best-of-breed technology solutions that deliver measurable benefits for sponsors, sites, and patients. This approach helps clients leverage the latest innovations to streamline processes, enhance data quality, ensure regulatory compliance, and, ultimately, simplify and accelerate the development of ground-breaking products. #technologyinnovation #clinicaltrials #IVD #medicaldevice

??ESSENVIA ESSENTIALS: FIVE YEARS AFTER RECOGNIZING THE FIRST COLLABORATIVE COMMUNITIES – public/private safe spaces where MedTech manufacturers and other stakeholders can candidly address an array of issues – the Food and Drug Administration (FDA) says it's participating in another three. The US agency now recognizes the?Implantable Brain-Computer Interface Collaborative Community (iBCI-CC), the OpenOximetry Collaborative Community, and the Smart and Autonomous Medical Systems (SaAMS) Collaborative Community. A collaborative community is an ongoing forum where private and public entities, including the FDA, work together on medical device challenges to discover common objectives and outcomes. Collaborative communities are “convened by interested stakeholders and may exist indefinitely, produce deliverables as needed, and tackle challenges with broad impacts,” the agency said in 2019 when announcing the first two communities, the National Evaluation System for health Technology Coordinating Center (NESTcc) Collaborative Community and the Ophthalmic Imaging Collaborative Community. The FDA doesn’t establish, lead, or operate collaborative communities, and communities are not required to advise the agency. Rather, the FDA “may participate as a member of the collaborative community and consider adopting the solutions developed by the body,” it says. A listing of collaborative communities and more information about them is at?https://rb.gy/gnsuw1. ??Essenvia Essentials: Bite-Sized MedTech News for RA Professionals?? Founded in 2018,?Essenvia?is a MedTech RIM platform that gives you the tools you need to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Discover more about what Essenvia can do for your MedTech company at Essenvia.com. #FDA #CDRH #CollaborativeCommunities #MedTech #MedicalDevices #Regulatory #RegulatoryManagement #Essenvia #RIM

What if I told you that you CAN go from single-use to reusable medical devices and IMPROVE the user experience? By combining user-centric design thinking and planet-centric sustainable design of course! My colleague Stephanie Mou will be presenting a unique approach that we've been developing that frames these key objectives in one lens - enabling multiple stakeholders to collaborate in finding the optimal path. There is a trick to developing product concepts that delight users and reduces impact on the environment - come watch Stephanie's talk so you don't miss it! #patientcentred #sustainability #medicaldevices Susana (Su) Osório, Lizzie Thomas, Paramesh Natarajan, Viviane Mosso, Pierre Gautier, Matthew Allen, Rachel Striebig

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